中關村(000931.SZ):北京華素的鹽酸曲馬多片一致性評價申請獲受理
格隆匯1月13日丨中關村(000931.SZ)公佈,公司下屬公司北京華素製藥股份有限公司(簡稱:北京華素)於近日收到國家藥品監督管理局簽發的《受理通知書》,鹽酸曲馬多片(規格:50mg)一致性評價申請獲得受理。
曲馬多是一種阿片受體激動劑以及去甲腎上腺素和5-羥色胺再攝取的抑制劑;因與μ-阿片受體結合,同時對去甲腎上腺素和5-羥色胺再攝取的輕微抑制,而具備鎮痛作用。臨牀上用於治療疼痛程度嚴重到需要使用阿片類鎮痛劑並且替代療法不足的成人疼痛。本品原研未在中國境內上市,目前境內已有8家仿製藥獲批上市,其中2家通過一致性評價;北京華素是第3家提交本品一致性評價申請的境內企業。截至公吿披露日,鹽酸曲馬多片項目已累計投入研發費用551.58萬元。
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